The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

21976–22000 of 50429

  • HighFDA (Devices)·Z-0079-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Titanium Abutments

    Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0084-2021·2020-10-14

    Biomet ARTHROSIMPLICITY KIT EU Recalled Due to Sterilization Defect

    Biomet is recalling ARTHROSIMPLICITY KIT EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V634000·2020-10-14

    Commercial trucks recalled for incorrect axle weight rating labels

    Daimler Trucks North America is recalling approximately 53 units of 2020-2021 Western Star and Freightliner commercial trucks due to incorrect Gross Axle Weight Rating information on vehicle certification labels. This could lead to axle overloading and increased crash risk.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 4700, 4900, 108SD, 114SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0083-2021·2020-10-14

    Biomet ONPOINT SCOPE PROCEDURE KIT-EU Recalled for Sterilization Defect

    Biomet, Inc. is recalling ONPOINT SCOPE PROCEDURE KIT-EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2021·2020-10-14

    Medline Recalls Non-Sterile Vascular Surgery Kits Sold Without Sterilization Capability

    Medline Industries is recalling 80 non-sterile vascular surgery kits sold to accounts without sterilization capabilities. The kits were distributed nationwide, including in CA, CO, CT, OH, TX, and NY.

    Product
    Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0051-2021·2020-10-14

    Ansell Microflex Diamond Grip Examination Gloves Recalled for Barrier Integrity Verification

    Ansell Healthcare Products LLC is recalling Microflex Diamond Grip Examination Gloves because they were shipped without verification of barrier integrity.

    Product
    MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0064-2021·2020-10-14

    Medline Recalls Non-Sterile MTO Protection Station Plus Kits

    Medline is recalling 80 non-sterile MTO Protection Station Plus kits because they were sold to facilities without sterilization capabilities.

    Product
    Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2021·2020-10-14

    Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability

    Medline is recalling 16 non-sterile left heart kits sold to accounts without sterilization capabilities. The kits require sterilization prior to use.

    Product
    Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0063-2021·2020-10-14

    Medline Recalls Non-Sterile Radiology Kits Sold Without Sterilization Capability

    Medline Industries is recalling 20 non-sterile radiology kits that were sold to accounts without the ability to sterilize them prior to use.

    Product
    Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0061-2021·2020-10-14

    Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability

    Medline Industries is recalling 60 non-sterile Left Heart Kits sold to accounts without sterilization capabilities. The kits were distributed nationwide.

    Product
    Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0066-2021·2020-10-14

    Medline Recalls Non-Sterile Cath Lab Kits Sold Without Sterilization Capability

    Medline Industries is recalling 32 non-sterile cath lab kits because they were sold to accounts without the capability to sterilize them prior to use.

    Product
    Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0028-2021·2020-10-14

    Tampa Bay Fisheries Recalls Taco Seasoned Salmon for Undeclared Soy

    Tampa Bay Fisheries is recalling Taco Seasoned Salmon products due to undeclared soy. The recall affects 75 cases distributed in San Antonio, Texas.

    Product
    Meal Simple Taco Seasoned Salmon Over Fire Roasted Vegetables and Grains, Net WT. 10.8 oz (306g), Use By Date of 2020-9-24.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0073-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments

    Biomet 3i, LLC is recalling BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.

    Product
    BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0069-2021·2020-10-14

    Nuvasive Precice Bone Transport System Recall for Distal Plug Disassociation Risk

    Nuvasive is recalling 41 Precice Bone Transport System units because standard removal tools can cause the distal plug to disassociate during explantation.

    Product
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0058-2021·2020-10-14

    Medline Recalls ClearPro Closed Suction Catheters Due to Assembly Separation

    Medline Industries is recalling 6,225 ClearPro Closed Suction Catheters because the catheter may separate from the device assembly during use.

    Product
    ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0065-2021·2020-10-14

    Medline Recalls Non-Sterile Cath Lab Kits Sold Without Sterilization Capability

    Medline Industries is recalling 16 non-sterile cath lab kits that were sold to accounts without the ability to sterilize them prior to use.

    Product
    Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0050-2021·2020-10-14

    Ra Medical Systems Recalls DABRA RA-308 Excimer Laser Units

    Ra Medical Systems is recalling 54 DABRA RA-308 Excimer Laser units because a taller wheel mounting may cause the device to fall over, potentially injuring users or patients.

    Product
    DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20E077000·2020-10-13

    Diode Dynamics Recalls SL1 LED Headlamp Bulbs for Excessive Glare

    Diode Dynamics is recalling specific SL1 LED headlamp bulbs that exceed brightness standards and may cause glare to oncoming drivers, increasing crash risk.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS:BULBS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V625000·2020-10-09

    Toro Recalls 2017-2020 Log Splitters Due to Tow Pole Mounting Plate Defect

    The Toro Company is recalling 2017-2020 model 22618 and 22618HD Log Splitters because tow pole mounting plates could bend, causing bolts to break and increasing crash risk.

    Product
    TORO — TORO LOG SPLITTER
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-10092020-01·2020-10-09

    Taylor Farms Recalls Ready-to-Eat Spaghetti Squash Bowls Due to Glass Contamination

    USDA FSIS issued a public health alert for Taylor Farms ready-to-eat spaghetti squash bowls produced in October 2020 due to possible glass contamination.

    Product
    Taylor Farms TX, Inc. — FSIS Issues Public Health Alert for Ready-To-Eat Meat and Poultry Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·20E076000·2020-10-08

    Chrysler Recalls Mopar Driver Side Mirror Glass for Detachment Risk

    Chrysler is recalling specific Mopar driver side mirror glass parts that may detach from the backing plate, reducing visibility and increasing crash risk.

    Product
    VISIBILITY:REARVIEW MIRRORS/DEVICES:EXTERIOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V624000·2020-10-08

    Harley-Davidson Recalls 2020 LiveWire Motorcycles for Software Defect

    Harley-Davidson is recalling 2020 LiveWire motorcycles because a software issue may cause the electric powertrain to shut down unexpectedly, increasing crash risk.

    Product
    HARLEY-DAVIDSON/LIVEWIRE — HARLEY-DAVIDSON/LIVEWIRE ELW (LIVEWIRE)
    Category
    Vehicle
    Distribution
    Distributed nationwide